They may be highly detailed working documents which direct specific personnel through specific tasks, or may be less well defined, covering the essential principles of Clinical Data Management. SOPs are dynamic documents which require regular review in order to meet the requirements of new regulations, company policy, or new technologies. The SOP Working Party was set up in October 1993 to develop some initial ideas put forward by the Data Quality Control Special Interest Group. The group consisted of representatives of Clinical Data Management groups from various pharmaceutical companies and clinical research organisations, and regular meetings were held in order to produce and finalise the documents. The aim of the group was to produce guidelines for the preparation of SOPs for Clinical Data Management. These guidelines, which conform to a recommended format and provide example information for content, could serve to form a possible basis from which Clinical Data Management groups across the industry could develop their own company-specific procedures. SOPs need to cover every Clinical Data Management activity from the preparatory stages such as clinical protocol review, through to the production of data for the final study report.
Standard Operating Procedures (SOPs) are guidelines which are instaIled by an organisation to ensure the consistent approach by those involved to that organisation’s activities. Within Clinical Data Management, such SOPs are an essential foundation for ensuring that current guidelines, e.g. Good Clinical Practice (GCP) are adhered to in producing reliable clinical data.
Academic researchers are increasingly supporting their clinical research through the development of novel electronic technologies. These can take many forms such as tools, devices, systems,…
The purpose of the 1st Edition of the Guideline was to suggest approaches by which validation might be achieved. The 2nd Edition updates these approaches…